NCT06115369Completed
Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure
Examining the Impact of Medically Tailored Meals vs Produce Supplements Delivered Conditionally vs Not on Health Engagement and Health Outcomes Among Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
The current study proposes to investigate if the provision of healthy food can improve outcomes following discharge after HF hospitalization. To investigate this in an efficient and pragmatic manner, a factorial randomized control trial design will be utilized to simultaneously investigate two separate, important food-related questions: * Does the provision of 90 days of either medically-tailored meals or fresh produce boxes improve 90-day patient outcomes among those with HF relative to a control group not receiving food supplements and instead receiving an equivalent monetary supplement? * Does receipt of the supplement in a conditional fashion, where the supplement is continued only if the participant attends follow-up visits or fills prescribed medications at the pharmacy, have more impact than providing unconditional supplementation?
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 24 Oct 2023
- Start date
- Apr 2024
- Primary completion date
- Oct 2025
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Heart failure
- NCT number
- NCT06115369
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From Apr 2024 to the primary completion date, Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of inotropic therapy at hospital discharge,
Other illness
- Baseline hyperkalemia with K \> 5.5 mEq/L or history of hyperkalemia requiring hospitalization for urgent treatment,
- Receipt of a heart transplant or left ventricular assist device,
Other
- Discharge to a skilled nursing facility or long-term care facility that provides prepared patient meals, comorbidity with expected survival \< 6 months, and
- Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters).
- Pregnancy
Who the study is looking for
- Adults over 18 years age with a recent hospitalization for acute decompensated HF
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
Related publications
- Food Supplementation in Patients Hospitalized for Heart Failure: A Randomized Clinical Trial.JAMA Cardiol · 2026 · PMID 41949846
This page is information, not medical advice. Discuss any trial with your doctor.